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BioWorld - Monday, September 16, 2024
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» FDA still playing catch-up on de novo device classifications
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FDA still playing catch-up on de novo device classifications
Sep. 4, 2024
By
Mark McCarty
The U.S. FDA is accused of dragging its feet on making public the devices for which it granted market access under the de novo program, and the agency recently been scrambling to bring these decision summaries to light.
BioWorld MedTech
Regulatory
U.S.
De novo
FDA